Prescription drug · ANDA
losartan potassium and hydrochlorothiazide NDC 71335-2827
Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2827-1 | 71335282701 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2827-1)Marketed from Oct 23, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- losartan potassium and hydrochlorothiazide
- Generic name (nonproprietary)
- losartan potassium and hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide — 12.5 mg/1Losartan potassium — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204832
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 71335-2827_41d8c6ba-7b9a-707f-e063-6394a90ae778SPL ID 41d8c6ba-7b9a-707f-e063-6394a90ae778SPL set ID 68a99bb3-69ad-42e2-9d50-390f75744671RxCUI 979464UNII 0J48LPH2TH, 3ST302B24A
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Thiazide Diuretic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471335282701followed by a unit qualifier and the quantityPackage 71335-2827-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) 1.1 Hypertension Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood press…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204832
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2462 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2461 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-190 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-191 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-192 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 12.5 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2662 |
| losartan potassium and hydrochlorothiazide | Hydrochlorothiazide 25 mg/1; Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-671 |